On January 2, 2018, the U.S. Food and Drug Administration (FDA) issued a Class I recall impacting 112 units of Agilis Steerable Introducer Sheath devices manufactured and sold by Johnson & Johnson between January 1st and May 5th, 2017. The Class I recall of the heart device is the strictest type of recall issued by the agency, and is only…
MEDICATIONS USED TO TREAT TYPE 2 DIABETES LINKED TO DIABETIC KETOACIDOSIS (DKA), ACUTE KIDNEY INJURIES, AND AN INCREASED RISK OF FOOT AND LEG AMPUTATION FDA HAS REVISED MEDICATION LABEL TO ADDRESS RISK
Medications used to treat type 2 diabetes Linked to diabetic ketoacidosis (DKA), acute kidney injuries, and an increased risk of foot and leg amputation
FDA HAS REVISED MEDICATION LABEL TO ADDRESS RISK
Attention: Have you or your loved ones been prescribed canagliflozin (Invokana, Invokamet) or dapagliflozin (Farxiga, Xigduo XR), a class of medications known as SGLT2 inhibitors prescription medications prescribed to control type 2 diabetes?
If so, please be advised that there have been numerous reports of patients with adverse reactions to these medications, including an increased risk for development of diabetic ketoacidosis (DKA), acute kidney injuries, and foot and leg amputation.
In response, the FDA has strengthened the existing warning about the risk related to these drugs, including revising the warnings on the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. The FDA advises patients that are currently taking CANAGLIFLOZIN (INVOKANA, INVOKAMET) AND DAPAGLIFLOZIN (FARXIGA, XIGDUO XR) to speak with their healthcare provider about any concerns.
To read the FDA Safety Announcement or Report any issues follow the link below:
FOR MORE INFORMATION, PLEASE VISIT THE FOLLOWING LINKS:
FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines CANAGLIFLOZIN (INVOKANA, INVOKAMET) AND DAPAGLIFLOZIN (FARXIGA, XIGDUO XR). https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
FDA Drug Safety Communication: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, https://www.fda.gov/Drugs/DrugSafety/ucm446852.htm
If you have concerns of injury as a result of taking one of these medications, including DKA, acute kidney injury, or foot and leg amputation, please call our office and ask to speak with Attorney Whitney Wallace Williams.
A Nationwide Voluntary Recall was issued for EpiPen and EpiPen, Jr. on March 31, 2017.
On March 31, 2017, the U.S. Food and Drug Administration (FDA) announced a Nationwide Voluntary Recall had been issued for EpiPen and EpiPen, Jr.
The Nationwide Voluntary Recall was issued by the drugs manufacturer MYLAN, due to a potential defect that could cause the device to be infective, leading to a failure that would prevent the appropriate delivery of the lifesaving medication to a patient that is having a severe allergic reaction.
The failure of an EpiPen or EpiPen, Jr. as described in the recall could result in serious injury or death for a patient having a severe allergic reaction.
This current recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of the device failing to activate due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Both reports are related to the single lot that was previously recalled.
The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.
EpiPen or EpiPen, Jr., are devices that deliver a dose of the lifesaving medication, epinephrine to patients experiencing a severe allergic reaction. In September 2017, the FDA sent a letter to the manufacturing facility that Mylan utilizes to produce the EpiPen or EpiPen, Jr., expressing a number of concerns, with the most alarming being that after receiving “hundreds of complaints” the company failed to investigate the potential for a deadly defect in the product.
Furthermore, the letter questions why, after defective devices were linked to patient deaths the company took no actions to investigate or correct issues related to the potential for failure of the devices until the FDA began investigations.
In addition to this Nationwide Voluntary Recall, Mylan issued another recall of EpiPens earlier this year. That recall impacted more than 20 lots of EpiPens. Mylan has also come under fire for increasing the price of the EpiPen. The price for the EpiPen has increased more than 400% in recent years. The company has also been investigated by the U.S. Justice Department for overcharging the government that ended with Mylan entering into a $465 million settlement with the agency.
For many, this has caused great concerns related to the safety and effectiveness of the products. If you are one of the thousands of people that have been prescribed or that stock EpiPen or EpiPen, Jr. in your emergency medical kit, please check the recalled lot information listed below.
If you or your family member has had an issue when using an EpiPen or EpiPen, Jr., that may have caused further health complications, it is important to report those issues to the FDA.
If you or a family member used an EpiPen or EpiPen, Jr., and experienced a failure of the device to function properly, resulting in additional health complications or death, those claims should be investigated. The attorneys at Wallace & Graham, P.A. are here to assist you, and investigate your claim.
For help investigating potential claims related to defective with an EpiPen or EpiPen, Jr., please contact our office at 1-800-849-5291.
FDA Information on the EpiPen or EpiPen, Jr. Nationwide Voluntary Recall
According to information posted on the FDA website, as of March 31, 2017, the recall effects 13 lots. The 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers, who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017
EpiPen® Voluntary Recall Website https://www.epipen.com/recall-information
FDA Company Announcement, March 31, 2017; Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector https://www.fda.gov/safety/recalls/ucm550173.htm
FDA Letter, Dated: September 5, 2017 to Meridian Medical Technologies, Inc. a Pfizer Company https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
Withdrawals, & Safety Alerts Website: https://www.fda.gov/safety/recalls/
How Consumers Can Report an Adverse Event or Serious Problem to FDA https://www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm
EpiPen cost soars, but it’s not the only drug to http://www.cnn.com/2016/08/23/health/epipen-price-mylan-prescription-drugs-increase/index.html
Mylan Wraps Up $465 Million U.S. Accord Over EpiPen Rebates https://www.bloomberg.com/news/articles/2017-08-17/mylan-agrees-to-465-million-settlement-of-u-s-epipen-claims
Photo credit CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=1193843
CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR) — FDA issues a safety warning related to diabetes medicine and amputations
Updated June 19, 2017 In the News: Drug Safety FDA issues a safety warning related to diabetes medicine CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR) On March 16, 2017, the Food and Drug Administration…
FDA issues a safety warning related to diabetes medicine CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR)
In the News: Drug Safety May 18, 2017 FDA issues a safety warning related to diabetes medicine CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR) On March 16, 2017, the Food and Drug Administration (FDA) issued a Drug Safety Announcement related to the diabetes medicine CANAGLIFLOZIN based on data from two large clinical trials. CANAGLIFLOZIN is used to treat individuals with type 2…